Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125396631 | 12539663 | 1 | I | 20120615 | 20160708 | 20160708 | EXP | JP-CIPLA LTD.-2012JP00597 | CIPLA | OKISHIO K, MIO T, KAWAHARA M, YOSHIOKA H, YANAGIHARA K, DAIMON T ET AL.,. A WEEKLY COMBINATION OF CARBOPLATIN AND IRINOTECAN FOR PREVIOUSLY UNTREATED EXTENSIVE DISEASE SMALL - CELL LUNG CANCER, RESULTS OF A MINIMUM FOLLOW-UP OF 3 YEARS: A MULTI-CENTER PHASE II TRIAL JMTO LC02-02. JAPANESE JOURNAL OF CLINICAL ONCOLOGY. 2012;42 (5):387 TO 393 | 0.00 | Y | 0.00000 | 20160708 | OT | JP | JP |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125396631 | 12539663 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | AUC 2, 30 MINUTE INFUSION ON DAYS 1 AND 8 | 77383 | ||||||||||
| 125396631 | 12539663 | 2 | SS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 50 MG/M2, 90 MINUTE INFUSION, ON DAYS 1 AND 8 | 0 | 50 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125396631 | 12539663 | 1 | Small cell lung cancer extensive stage |
| 125396631 | 12539663 | 2 | Small cell lung cancer extensive stage |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125396631 | 12539663 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125396631 | 12539663 | Leukopenia | |
| 125396631 | 12539663 | Pneumonia streptococcal |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |